Merck: FDA Accepts Keytruda SBLA as Adjuvant in Advanced Melanoma
June 25 2018 - 7:21AM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) on Monday said the Food and Drug
Administration accepted a supplemental Biologics License
Application for its Keytruda cancer drug as adjuvant therapy in
patients with resected, high-risk stage III melanoma, the most
serious form of skin cancer.
The Kenilworth, N.J., drug maker said the sBLA is based on a
significant benefit in recurrence-free survival shown by Keytruda
in a pivotal Phase 3 trial.
Keytruda, a new type of cancer drug that harnesses patients'
immune systems to fight tumors, is already marketed to treat lung,
skin, bladder and other cancers.
Merck said the FDA set a target action date of Feb. 16, 2019 for
the sBLA.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 25, 2018 07:06 ET (11:06 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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